Laboratory standards
Identity testing
Establishing that a material is the substance it is labelled as — a separate question from how pure it is.
Identity testing answers one question: is this material the substance named on the label? It is logically prior to every other test, because a purity figure, a content determination and a stability profile all describe whatever is actually in the container, correct label or not.
How identity is established
- Mass spectrometry, comparing the measured molecular mass against the mass calculated from the intended sequence. This is the usual first-line method for peptides.
- Sequencing, either by tandem mass spectrometry fragmentation or by Edman degradation, which reads residues directly rather than inferring them from total mass.
- Amino acid analysis, which hydrolyses the chain and quantifies the constituent amino acids, confirming composition without confirming order.
- Comparison against a characterised reference standard under identical analytical conditions, where such a standard exists.
A robust identity conclusion generally rests on more than one method, because each technique has a class of errors it cannot detect. Two independent methods agreeing is a materially stronger position than one method returning a confident-looking number.
References
- GuidanceCitation not yet verified
ICH guidelines (opens ich.org in a new tab)
International Council for Harmonisation · accessed 17 August 2026
- GuidanceCitation not yet verified
British Pharmacopoeia (opens pharmacopoeia.com in a new tab)
British Pharmacopoeia Commission · accessed 17 August 2026